The purpose of the study is to evaluate the efficacy and safety of transbronchial ICG and percutaneous hook-wire assisted Video-assisted thoracoscopic sublobar resection. In the control group, CT-guided percutaneous hook-wire preoperative localization will be used for surgical resection; In the experimental group, electromagnetic navigation bronchoscopy guided transbronchial ICG injection will be performed for localization before VATS.
This is a single-center, prospective, randomized trial initiated by the investigator. Subjects with pulmonary nodules who will undergo Video-assisted thoracoscopic sublobar resection will be randomly divided into two groups. In the experimental group, before the VATS operation, transbronchial ICG injection will be guided by electromagnetic navigation bronchoscopy to locate the nodule. In the control group, the subject will undergo CT guided hook-wire placement for nodule localization before VATS. The study is expected to enroll 188 patients. Finally, the effectiveness and safety of the two methods will be compared.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
188
Indocyanine green (ICG) was diluted with saline to 0.5mg/mL, and injected 0.6mL/site.
Electromagnetic navigation bronchoscopy (ENB) allows physicians to access peripheral lung nodules with high accuracy and provides a working channel for ICG injection.
Hook wire is a puncture locating needle with a hook head that is about 1 cm in length and 30 cm metal wire behind. Through the puncture path planned based on CT scan, hook wire puncture percutaneously into the chest cavity to reach the lesion for localization.
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGSuccess rate of the localization procedure
Calculated as follows: (number of successful targeting procedures/number of all localization procedures)\*100
Time frame: On the 1 day of localization operation
Success rate of the effective localization
Calculated as follows: \[(number of successful targeting procedures-number of dislodgements or unrecognized in the operative field)/number of all localization procedures\]\*100
Time frame: On the 1 day of VATS operation
Success rate of VATS sublobar resection
Calculated as follows: (number of successful VATS procedures/number of all localization procedures)\*100
Time frame: On the 1 day of VATS completion
Safety endpoint
Complication rate of two localization methods, including pneumothorax, hemorrhage, etc.
Time frame: On the 1 day of VATS operation
Localization time
The localization time of the control group was defined as the time from the first CT scan which set the path for percutaneous puncture, to the last CT scan which confirmed the hook wire located at the expected site. The localization time of the experimental group was defined as the time from the insertion of bronchoscope to the glottis, to the withdrawal of bronchoscope from the glottis after ICG injection.
Time frame: On the 1 day of localization operation
Operation time of VATS sublobar resection
The operation time is defined as the time from the start of the skin incision to the completion of the suture of the skin.
Time frame: On the 1 day of VATS completion
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